Acute Myocardial Infarction
Conditions
Keywords
myocardial infarction
Brief summary
Background: When an acute myocardial infarction occurs, the artery supplying the infarct zone should be opened within twenty four hours of onset of infarction. This has clearly been shown to be beneficial. If the patient presents later than 24 hours of onset, at that stage a large part of the damage to the heart is irreversible. Intervening at this stage (beyond 24 hours is controversial). Some trials suggest that opening the artery even at this stage positively modifies the remodeling process while other trials suggest that such a benefit is not seen. Hypothesis: Opening an infarct related artery after 24 hours (until 6 months) and combining it with intracoronary stem cell therapy may provide incremental benefit.It is possible that the lack of benefit seen with late revascularization (\>24 hrs) after MI may be offset by giving intracoronary stem cells after opening the artery.
Detailed description
Objectives The benefit of opening an infarct related artery after the period of myocardial salvage (In patients who do not come to medical attention within 24 hrs of an infarctions) has been questioned in recent trials. On the other hand, Stem cell therapy after myocardial infarction has been shown to improve myocardial function both in the acute and chronic phases. It is possible that the lack of benefit seen with late revascularization (\>24 hrs) after MI may be offset by giving intracoronary stem cells after opening the artery. Patients with recent myocardial infarction (MI) and occluded infarct related arteries supplying a large myocardial territory and with reduced ejection fraction will be randomized to a percutaneous coronary intervention (PCI) arm and a PCI plus stem cell arm . The objective of the trial is to demonstrate that opening an infarct related artery after 24 hours and before six months and following it with intracoronary stem cell therapy may provide incremental benefit. The primary objective To demonstrate benefits in left ventricular recovery (improvement in function by echocardiogram and Nuclear imaging: Multigated acquisition \[MUGA\], reduction in scar size by tetrofosmin scan/Positron Emission Tomography\[PET\]. ) The secondary objectives To demonstrate improvement in functional capacity as assessed by 6 minute walk test and quality of life assessment, along with reduction of first occurrence of recurrent MI, hospitalization/treatment of New York Heart Association class IV congestive heart failure, or death
Interventions
PROCEDUREIntracoronary stem cells injection
Intracoronary stem cells will be injected in the infarct related artery after a successful coronary dilatation and stenting autologous bone marrow stem cells from iliac crest 60 ml bone marrow will be extracted and purified for mononuclear cells which will be injected.
PROCEDUREcoronary dilatation and stenting
coronary dilatation and stenting
Sponsors
Indian Council of Medical Research
All India Institute of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age:18 to 80 years 2. Sex:Both 3. Recent MI (3-28 d) 4. Obstructed artery needing intervention 5. consent for stem cell therapy
Exclusion criteria
1. Left main disease or Triple vessel disease\[TVD\] needing surgery 2. Hypotension 3. Consent not given
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| left ventricular function | 3 Months | Change in left ventricular function (assessed by Nuclear imaging and ECHO) and change in myocardial viability \[assessed by PET\]. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in functional capacity | 3 months | change in functional capacity as assessed by 6 minute walk test, quality of life assessment, first occurrence of recurrent MI, |
Countries
India
Contacts
Primary ContactSandeep Seth, DM
Backup ContactS Seth
Outcome results
None listed